effectof fractal tones on the improvementof tinnitus ... · sents a natural brain function designed...

Effect of Fractal Tones on the Improvement of TinnitusHandicap Inventory Functional Scores among ChronicTinnitus Patients: An Open-label Pilot StudyPatricia Simonetti1 Laura Garcia Vasconcelos1 Jeanne Oiticica1

1Department of Otorhinolaryngology, Faculdade de Medicina daUniversidade de São Paulo, São Paulo, SP, Brazil

Int Arch Otorhinolaryngol 2018;22:387–394.

Address for correspondence Jeanne Oiticica, MD, PhD, Departmentode Otorrinolaringologia, Universidade de São Paulo, Alameda dosJurupis 657, CJ 72, Indianópolis, São Paulo, SP, 04088-002, Brazil(e-mail: [email protected]).

Introduction

Tinnitus is a common, persistent symptom characterized by asound sensation in the “ears” or “head” that is not produced bymechanical-acoustic signals fromtheexternalenvironment.1Arecent epidemiological study based on 1,960 interviews con-ducted in the city of São Paulo, Brazil, showed that 22% of theinhabitants had tinnitus,2 a higher prevalence than the 10–17%value commonly reported in the literature.3,4Wealsoobserved

that the prevalence of the symptoms increases progressivelywith age and can be three times higher in the elderly (36% over65 years of age) than that in young adults (12%).2 Many of thetinnitus sufferers also exhibited hearing loss and hypersensi-tivity to sound.5,6 Various pathophysiological causes underlietinnitus, and all of the associated symptoms interfere withevaluations of affected patients. For most patients, medicalmanagement and appropriate counselling suffice; however, forother patients, the symptoms are persistent and bothersome,

Keywords

► tinnitus► fractal► music therapy► THI

Abstract Introduction Music-based sound therapies become recently a trend in the treatmentof tinnitus. Few publications have studied the therapeutic use of fractal tones to treatchronic tinnitus.Objective The aim of this study was to determine the benefits of using fractal tones asa unique sound therapy for chronic tinnitus sufferers.Methods Twelve participants were recruited; however, six could not be assigned. Atbaseline and at 1, 3 and 6 months, the participants were provided with the TinnitusHandicap Inventory (THI) and Hearing Handicap Inventory for Adults (HHIA) ques-tionnaires, and their visual analog scale score was recorded. Tinnitus pitch andloudness matching was performed before fitting and after 6 months of use.Results The visual analog scale (VAS) score, pitch and loudnessmatching andminimalmasking levels did not result in significant improvement at the end of the treatment.The mean THI measured at baseline was 45, and the final one was 25. A paired samplet-test showed that this 20-point difference was statistically significant.Conclusions We measured the benefits of using fractal tone therapy for the treat-ment of chronic tinnitus and found that most of the benefits were in the THI functionaldomain, which includes concentration, reading, attention, consciousness, sleep, socialactivities, and household tasks. For all patients with bothersome chronic tinnitus andhigh scores on the THI functional scale, fractal tones should be considered a promisinginitial sound therapy strategy. The findings from this open-label pilot study arepreliminary, and further trials are needed before these results can be generalized toa larger tinnitus population.

receivedJune 13, 2017acceptedFebruary 19, 2018published onlineMarch 29, 2018

DOI https://doi.org/10.1055/s-0038-1635575.ISSN 1809-9777.

Copyright © 2018 by Thieme RevinterPublicações Ltda, Rio de Janeiro, Brazil

THIEME

Original Research 387

and they interfere with daily activities and with the quality oflife. A recentU.S. study found that nearlya quarter of thosewhoreported tinnitus symptoms described it as disabling,7 andaccording to Brazilian data, � 34% of cases are severelyannoying.2

The habituation theory8 and the neurophysiologicalmodel of tinnitus proposed by Jastreboff in 1990 providednew approaches for the clinical treatment of patients withtinnitus. Several therapeutic approaches have been proposedbased on these models, including TRT (tinnitus retrainingtherapy), TAT (tinnitus therapy activities) and many otherprotocols that combine counselling, sound therapy andrelaxation.9,10 These approaches combine sound therapy(as a facilitator) with procedures to habituate the reactionscaused by tinnitus and its perception, thereby resulting in adecreased conscious perception of the signal. Sound therapy,such as sound amplification or the use of sound generators,aims to decrease the contrast in quiet environments andpromote sound enrichment to facilitate habituation andprovide partial or total masking of tinnitus.

Currently, different forms of sound therapy are available,and several forms of stimuli can be delivered from sounddevices, which can be combinedwith amplification. Tinnitusprimarily occurs because of sensory deprivation andincreased central neural activity. A hearing aid can restorethis system and is an effective treatment that has beenconfirmed by several studies. Other studies have revealedthat music has great therapeutic potential for tinnitusrelief.11,12 Listening to music leads to relaxation and stressrelief, both of which can contribute to tinnitus control. Inpatients suffering from tinnitus, the presence of an annoying,persistent, and uncontrolled out-of-context sound signal canincrease stress levels and cause an emotional disturbancethat can exacerbate the perception of tinnitus. Neuroimaginghas revealed the brain structures involved in tinnitus per-ception, which include the hippocampus, limbic area, frontallobe, and cerebellum. These areas are also highly activatedwhen listening tomusic.13–15Music can be customized16 andfiltered in accordance with the individual’s hearing loss andtinnitus pitch and listening to pre-recorded music providesthe patients with a structured listening protocol.

Fractal tones are harmonic and melodic tones that soundlike “windchimes”; however, because theyarenot predictable,these tones cannot be associated with any other conventionalmusic towhich thepatientmayhavebeenpreviously exposed.This unpredictability is a unique and desirable feature offractal tone music sound therapy because it induces passivelistening,which is required forhabituation.Habituation repre-sents a natural brain function designed to reduce neutralstimulus perception under repeated exposure. Recent studieshave shown that the use of fractal sounds may represent aviable alternative for minimizing the annoyance caused bytinnitus.17 Fractal tones appear to lead the listener to apleasant and relaxing auditory experience and induce greaterrelaxationandstress reliefcomparedwithconventionalmusic.In an open-label clinical trial, 14 hearing-impaired adultswitha primary complaint of tinnitus were provided with one ofseveral programs, including amplification only, fractal tones

only, and a combination of amplification, white noise and/orfractal tones. Although the results did not show that the use offractal tones was advantageous over the other treatmentprotocols, thepatientspreferred listening to those tones ratherthan noise over long periods. However, the role of fractal tonesalone on chronic tinnitus sufferers is difficult to determinebasedonthestudy reportedabove17becausethe reportdidnotinclude the number of patients that used the fractal device oramplification alone, and the results were too similar amongthe four studied groups.

Music-based sound therapies have recently become a focusof tinnitus treatment because they target two of the mechan-isms that are assumed to underlie tinnitus: perception andreaction. Such targeting has not been previously attributed to awhite noise device. The few publications that have studied thetherapeutic useof fractal tones among chronic tinnitus patientshave rarely investigated the contribution of fractals separatelyfrom other techniques, such as amplification, white noise,cognitivebehavioral intervention, andrelaxationexercises.17–21

ObjectivesThe aim of this study was to determine the benefits of fractaltones as a unique sound therapy for treating chronic tinnitus.

Patients and Methods

The study was conducted at the Tinnitus Research Group ofthe Otolaryngology Department at the Clinical Hospital ofthe School of Medicine of Universidade de São Paulo. Thesample consisted of subjects with normal listening abilityand tinnitus sufferers who had mild hearing loss but nohearing loss complaints. These subjects were not using anyother treatment or medication during the investigation. Theparticipants were selected from August of 2014 to Decemberof 2015, and they signed an informed consent and agreed toparticipate in the study.

Inclusion CriteriaThe inclusion criteria were as follows:• Normal listeners• Mild sensorineural hearing loss (no hearing difficulties)

that did not exceed 40 dBHL from 250 to 8,000 Hz• Chronic tinnitus that has persisted for more than 6months• Tinnitus annoyance and handicap discomfort that are

moderate, severe, or catastrophic as measured by theTinnitus Handicap Inventory (THI, which was translatedinto and validated using the Portuguese language22)

Exclusion CriteriaThe exclusion criteria were as follows:• Pulsatile and/or somatosensory tinnitus• Patients with psychiatric disorders• Individuals with motor, visual and/or cognitive functions

that prevent the implementation of the procedures andthe handling of hearing aids

• Patients prescribed antidepressants, anxiety drugs orsleeping pills

• History of drug abuse

International Archives of Otorhinolaryngology Vol. 22 No. 4/2018

Fractal Tones Effect for Tinnitus Simonetti et al.388

Methods

This study was approved by the Ethics Committee of theSchool of Medicine – Universidade de São Paulo - protocolnumber 611.174.

The participants were subjected to anamnesis, ENT (earnose and throat) physical examination, and a completeaudiological evaluation, which included pure tone audio-metry by air and bone conduction at frequencies from250 Hz to 8,000 Hz as well as speech audiometry andacoustic immittance audiometry test measures. In additionto the audiological evaluation, the participants underwentpitch and loudness matching and minimum masking level(MML) measurements. These measurements were used tocheck for changes in the perception of tinnitus before andafter fitting the device. Many other studies, including pre-vious fractal studies, have not used psychoacousticmeasuresof tinnitus.20,21 Our research team protocol uses thesepsychoacoustic measures routinely for all patients on theirfirst visit and after treatments, especially sound therapy. Thetinnitus impact and hearing handicap were assessed usingthe THI, HHIA (Hearing Handicap Inventory for Adults)23 andVAS (visual analog scale).

All subjects were administered instructional counselling atthe beginning of the study. Comprehensive information on thebasic hearing anatomy and physiology, the tinnitus etiology(that is, a natural consequence of hearing loss), the usualtinnitus course, the strong relationships between hearing andemotions, the potential negative associations with regard tohearing loss and the habituation process were also explained.

The fractal tones were delivered using MENU behind-the-ear hearing aids (Widex, Lynge, Denmark). All participantswerefittedwith the devices in both ears, and all wore them asopen fittings, meaning that their earswere as open as possibleto minimize the effects of occlusion and physical discomfort.

Of the five available styles of fractal tones (one of the fourWidex Zenprogram components), the “Aqua style”was chosenbecause it was preferred by every participant during thefittingsession. Amplificationwas not provided. The participantswereinstructed to use the device as frequently as possible and for atleast 8 hours each day depending on their level of comfort withthe device. The participants were also instructed to use thedevice during sleep. Adjustments to the fractal tones wereperformed by the audiologist to ensure that the tones wereaudible in quiet environments and did not interfere withconversational speech. To ensure that the device was usedeffectively and guide the participants regarding the device’sability to control tinnitus perception, we followed the partici-pants for at least 6 months via individual counselling sessions.

The participants answered the questionnaires and werescored on the VAS scale at baseline, 1 month, 3 months and6months. The participants’ hearing aid data log was checkedat the meetings to certify that the device was continuallyused. Tinnitus pitch and loudness matching was performedbefore fitting and after 6 months of use.

The study involved1 an audiologist, who was responsiblefor fitting the devices;2 a physician, who was responsible foradministering the clinical evaluations and questionnaires;

and3 a second audiologist, who conducted all audiologicaltests and psychoacoustic measures of tinnitus.

The variables sex, age, and time of tinnitus were describedaccording to their frequency. The quantitative variables (THI,VAS, pitch/loudness, and LMM)were described asmeans andstandard deviations (SDs). The statistical associations foreach situation (before and after device use) were comparedusing the Student t-test for quantitative variables, and thestatistical significance was set at p < 0.05.

Results

Twelve participantswere recruited, although six could not beassigned because they were already taking medicine fortinnitus treatment or had another acoustic stimuli prefer-ence. Four females and twomales (mean age, 52 years; range,34 to 70 years) were enrolled, and five participants com-pleted the data collection. ►Table 1 shows the etiology ineach case. Two participants complained of tinnitus in one earonly, and the other four complained of a tinnitus sensation inboth ears or in their heads. All subjects had tinnitus for morethan 1 year, and three had tinnitus for more than 5 years.Although hearing loss had occurred in several subjects, it wasnot a complaint and did not exceed 40 dBHL at any frequency.This finding was confirmed by the HHIA scale instrument,which was used to determine hearing loss that may repre-sent a contributing factor to tinnitus annoyance. The HHIAscore among almost all participants was less than 12, indi-cating no hearing difficulties. In ►Fig. 1, audiograms of oursample are presented.

The tinnitus pitch, loudness, and MMLs were measured atbaseline. The mean pitch was 6,033 Hz (range, 500 to11,200 Hz; SD, 4,462 Hz). The mean loudness was 9.8 dBSL(range, 5 to 21 dBSL; SD, 6.2 dBSL). ThemeanMMLwas 8 dBSL(range, 2 to 20 dBSL; SD, 6.3 dBSL). After 6 months of usingthe fractal tone device, all measurements were performedagain. Results showed amean pitch equal to 5,240 Hz (range,500 to 11,200 Hz; SD, 4,708 Hz), a mean loudness equal to7 dBSL (range, 5 to 12 dBSL; SD, 2.9 dBSL), and ameanMML of7 dBSL (range, 3 to 15 dBSL; SD, 4.7 dBSL). None of thefollowing measurements showed significant improvementsat the end of the treatment: pitch (paired t-test; two-tailedp value ¼ 0.3739), loudness (paired t-test; two-tailed p value¼ 0.3796), and MML (paired t-test; two-tailed p value¼ 0.1302). The mean values, SDs and results are illustratedin ►Table 2.

Table 1 Etiology of subjects

Subjects Etiology

1 Post-traumatic stress disorder

2 Metabolic syndrome

3 Endolymphatic hydrops

4 Otitis media

5 Idiopathic

6 Acoustic Trauma


Fractal Tones Effect for Tinnitus Simonetti et al. 389

Fig. 1 Audiograms of the six participants in the fractal study. Abbreviations: dB, decibels; LE, left ear; RE, right ear; SDT, speech detectivethreshold; SHT, speech hearing threshold; SRT, speech reception threshold.

Table 2 Mean, standard deviation and loudness, pitch and minimummasking level values obtained at baseline and after 6 months

VAS Loudness� Pitch�� MML�

A0 A6 A0 A6 A0 A6 A0 A6

Mean 7 5.6 9.8 7 6033 5240 8 7

SD 0.8 1.3 6.2 2.9 4462 4708 6.3 4.7

P 0.1087 0.3796 0.3739 0.1302

MSD No No No No

Abbreviations: A0, at baseline; A6, after 6 months of device use; MSD, mean significant difference at p < 0.05; P, t-test p value; SD, standarddeviation; VAS, visual analog scale.� ¼ measured in dBSL (decibels, that is, sensation level)�� ¼ measured in Hz.



At baseline, the mean VAS score was 7 (range, 6 to 8), andafter 6 months of treatment, the mean VAS score was 5.6(range, 4 to 7). Although a slight improvement was observedfor all subjects, the results were not statistically different(paired t-test, two-tailed p value ¼ 0.1087).

ThemeanTHImeasuredat baselinewas45 (range, 30 to 66),and thefinal THIwas25 (range, 18 to30).Apaired sample t-testshowed that the 20-point difference was statistically signifi-cant (p < 0.05). The SDs, significantdifferences and confidenceintervals are shown in ►Table 3. ►Fig. 2 illustrates themeasured values.

The following three THI subscales were also analyzed:functional, emotional, and catastrophic factors. All of theseaspects improved after 6 months of treatment; however, onlythe functional aspect showed a statistically significant differ-ence. The results are also shown in ►Table 3 and ►Figs. 2–3.

Discussion

A self-reported survey using the 1999–2004 National Healthand Nutrition Examination Surveys (NHANES) databaseshowed that more than 14,000 subjects among the U.S. adultpopulation reported having tinnitus. Among nine assessedtinnitus treatment methods (hearing aids, music, medication,relaxation exercises, counselling, non-wearable sound gen-

erators, herbs and dietary supplements, wearable sound gen-erators, and psychological counselling), substantial tinnitusamelioration was only observed for the treatments withhearing aids (34%) and music (30%).7 This finding was one ofthe motivations for our investigation into the effects of musicon chronic tinnitus sufferers.

Thefirst reportof theuseofmusic for tinnitusmanagementwaspublished in 1988; in this study,music and different typesof tinnitus maskers were compared, and music was recom-mendedover traditionalmaskers for thefirst time.24However,music did not achieve widespread use as a form of soundtherapy until recently.16,25,26 Neuromonics is one of the firsttinnitus music sound therapies to use pre-recorded custo-mized music (increased intensity) in accordance with theindividual’s hearing loss and tinnitus pitch.16 Anothersound-based music technique is the tailor-made notchedmusic trainingendeavor,whichpresentsanopposite approachto that of Neuromonics because it removes the tinnitusfrequencies and neighboring frequency regions from themusic.26 Fractal tones have a sound that is similar to windchimes, and which can be processed using an algorithm tocreate a melodic chain of tones that are sufficiently repetitiveto sound familiar and sufficiently varied to avoid predictabil-ity.27 In addition, fractal tones emphasize certain musicalelements, such as a slowonset, slower tempo (near the restingheart rate of � 60–72 beats/minute), lower pitch, repetition,non-emotional content (to avoid evoking memories), and thecombination of these elements produce a soothing effect andheightened concentration in certain individuals.28

Thus, ENT doctors and audiologists can select from awidevariety of tinnitus music sound therapy styles (for example,fractal tones, Neuromonics, tailor-made notched music),although the styles that best suit each type of tinnitus patientare unknown. Therefore, our aim was to verify the effective-ness of fractal tones on tinnitus perception, annoyance, andmagnitude among chronic tinnitus sufferers recruited fromthe Tinnitus Research Group of the Otolaryngology Depart-ment of the Medical School at Universidade de São Paulo.Patients with moderate, severe, or catastrophic chronictinnitus, as measured by THI, were selected. These patientshad experienced a positive impact on their quality of life buthad not complained of significant hearing loss as measuredby the HHIA. Moreover, these patients were likely to benefitfrom sound therapy without amplification because our goalwas to verify the effect of fractal tones alone.

Table 3 Mean, standard deviation and differences for the THI and its subscales at baseline and after 6 months

THI FS ES CS

A0 A6 A0 A6 A0 A6 A0 A6

Mean 45.17 25.60 18.17 8.40 17.7 10.80 9.83 6.40

SD 11.84 4.77 6.46 0.89 4.02 1.78 4.21 3.28

P 0.0136 0.0245 0.0579 0.0743

MSD Yes Yes No No

Abbreviations: A0, at baseline; A6, after 6 months of device use; CS, catastrophic score; ES, emotional score; FS, functional score; MSD, meansignificant difference at p < 0.05; P, t-test p value; SD, standard deviation; THI, tinnitus handicap inventory.

Fig. 2 Tinnitus handicap inventory scores measured before and after1, 3 and 6 months of fractal therapy. �, significant difference(p < 0.05).



Among the excluded tinnitus patients, onewas amusicianwho dropped out because due to considering fractal tones tobe annoying. This reasoning was consistent with the resultsof a previous similar report17 because a universal soundtherapy that suits and works for all tinnitus patients has notbeen identified, and certain types of music stimuli inducerelaxation in some individuals but not others.28

We followed most of the assigned patients for 6 monthsand others for 1 year. All patients were instructed to listen tothe fractal tones during waking hours, and our data loganalysis showed that the fractal tones were used for at least8 hours per day on average. The recommended time frame of8 hours per day is inconsistent with the recommendations inother studies, inwhich the recommended use of fractal toneswas only for 2 or 4 hours each day.17 After a 6-month period,certain patients decided to keep the device because theywere using it throughout the day. However, other patientswho did not observe considerable improvements or tinnitussuppression stopped using the device continuously after theend of the study. After the 6-month period, certain patientshad worsened hearing thresholds and were subsequentlyfitted with a hearing aid amplification, which representedthe best initial time point for selecting the combined hearingaid/sound therapy device. During the study period, only the

Aqua fractal style was used per the participants’ choice. Thisstyle was also the most preferred by participants in anotherstudy.18

After the sound therapy period, certain patients indicatedexperiencing a clinical improvement in their daily quality oflife, which included better concentration while reading orstudying and a greater ability to relax. Two participants usedthe device to sleep because sleep problemswere among theirmain complaints. All six participants (100%) showed a clin-ical significant improvement in their THI scores, whichdecreased by almost 20 points (the mean score at baselinewas 45.1 and themean score after 6months of sound therapywas 25.6), and this finding is consistent with a previousreport in which a 30-point improvement in THI wasobserved.20 Previous studies have indicated that 20-pointTHI score changes are clinically significant.29 According toour data, the THI changes were only clinically significant atthe final appointment after 6 months of therapy. Thesefindings are inconsistent with those of previous studies inwhich an earlier responsewas observed at 2months.20,21 Theauthors applied the Zen therapy, which includes the fourcomponents: fractal tones, broadband amplification, relaxa-tion exercises and sleep management, in 24 and 19 assignedparticipants subjected to THI and TFI (tinnitus functional

Fig. 3 Tinnitus handicap inventory functional, emotional and catastrophic scores measured at baseline and after 6 months of fractal therapy. �,significant difference (p < 0.05).



index) measurements, respectively. In that study, the posthoc analysis based on a paired sample t-test showed asignificant score reduction at 2 months, which indicatedthat earlier tinnitus distress resolution and habituationcould be achieved by the Zen therapy. However, the authorsused a simultaneous combination of tools, and the contribu-tions of each tool to the observed tinnitus improvement isunclear. Based on our results, we aimed to determine thespecific benefits of fractal tones for tinnitus sufferers with-out combining it with other therapeutic strategies, and ourinstructions recommended the use of this therapy for at least8 hours each day.

In another study that was similar to ours,30 the authorinvestigated the effectiveness of fractal tones in patientswithminimal hearing loss by comparing two groups (n ¼ 19/22)with the same tinnitus characteristics (THI > 18), and thecontrol group only received counselling. For 2 months, onlyfractal tones were employed in the study group, althoughamplification was subsequently provided for those who hadnot been responsive to fractal tones, and who indicated thatthey experienced hearing loss. For those with normal hear-ing, other components of Widex Zen Therapy (WZT) wereadded, such as cognitive behavioral therapy and relaxationexercises. Clinical and statistically significant improvementswere observed in the study group (21 points on the TFI) forthe first 2 months, and the patients continued to improveuntil the 6th month. The author also investigated the long-term effects at 6 months after the end of the treatment andverified that the participants who continued to use thedevice maintained the benefits of treatment, whereas thosewho stopped using the device did not maintain any benefits.This finding was also observed in several of our participants.

The THI is a 25-item self-reporting instrument that isgrouped into three subscales or domains. The functional sub-scale reflects limitations experienced by the patient inmental,social/occupational, and physical functioning areas; the emo-tional subscale includes abroad rangeofemotional reactions totinnitus; and the catastrophic subscale includes thedestructiveeffects of experiencing tinnitus. We determined the subscalesor domains that were responsible for the THI score improve-ment after the 6-month fractal sound therapy, and our resultsindicated that the primary result of this type of sound therapywas a decrease in the scores on the THI functional scale, whichmeasures concentration, reading, attention, consciousness,sleep, social activities, and household tasks. This finding wassurprising and inconsistent with previous studies in whichfractal tones were reported to promote improvements in theemotional and catastrophic responses.19–21 In our study, nostatistically significant changeswereobserved in the results forthe THI emotional and catastrophic domains recorded at base-line and at the 6-month evaluation.

The VAS, pitch and loudnessmatching, andMMLs showed aslight tendency toward improvement in certain participants;however, our limited sample size precluded the detection ofclinically significant differences in thesemeasures or any typeof improvement in the tinnitus magnitude after 6 months offractal sound therapy. Because tinnitus can exacerbate stress(and vice versa), relaxation and proper sleep schedules are

important for tinnituspatients,whoare instructed tocontinuewith their lives and common routine. Although we did notexpect to observe drastic changes in the psychoacousticmeasures, we did expect to observe changes in the partici-pants’ reactions to tinnitus and the impact of tinnitus on theirquality of life. These changes were detected by the THI, whichindicated that the greatest changes occurred in the functionaldomain, as well as by the participants’ spontaneous reportsregarding improvements in their attention and concentration.

Many different stimuli can be delivered by differentdevices used in sound therapy. Such therapies can be appliedin various strategies to control tinnitus. For example, thesetherapies can be used to mask the tinnitus, avoid silence,diminish contrast, thus facilitating tinnitus management.However, these therapies are not effective for every patient,and the research remains inconclusive.

Tinnitus has different underlying causes; therefore, everypatient and treatment strategy are unique. Fractal tones arerecommendedasasoundtherapybecausethis techniqueclearlyhelped participants to concentrate and manage the associateddistress, and it facilitated sleep in certain participants.

We suggest that a combination of fractal tones with otherelements, such as relaxation techniques, will be beneficial fortinnitus sufferers.

The results of our study support the use of fractal tones asa sound therapy for tinnitus patients. We also recommendfuture research on the long-term effects of this therapy.

Conclusions

We traced the individual contributions of fractal tones onchronic tinnitus sufferers and found that the main benefit ofthisapproachwas intheTHI functionaldomain,which includesconcentration, reading, attention, consciousness, sleep, socialactivities, and household tasks. For all patients with bother-some chronic tinnitus who have high scores on the THI func-tional scale, fractal tones should be considered as a good initialsound therapy. The findings of this open-label pilot study arepreliminary, and other trials must be conducted before theseresults can be generalized to a larger tinnitus population.

Conflict of InterestThe authors declare that the research was conducted inthe absence of any commercial or financial relationshipsthat could be construed as a potential conflict of interest.The MENU hearing aids used as the fractal tone deviceswere donated by Widex Hearing aids.

References1 Weisz N, Hartmann T, Dohrmann K, Schlee W, Norena A. High-

frequency tinnituswithout hearing loss does notmean absence ofdeafferentation. Hear Res 2006;222(1-2):108–114

2 Oiticica J, Bittar RS. Tinnitus prevalence in the city of São Paulo.Rev Bras Otorrinolaringol (Engl Ed) 2015;81(02):167–176

3 Davis A, Refaie AE. Epidemiology of tinnitus. In: Tyler R, editor.Tinnitus Handbook. San Diego (CA): Singular Publishing Group;2000:1–23



4 Henry JA, Dennis KC, Schechter MA. General review of tinnitus:prevalence, mechanisms, effects, andmanagement. J Speech LangHear Res 2005;48(05):1204–1235

5 Jastreboff P, Hazell JWP. Tinnitus Retraining Therapy: Implement-ing the Neurophysiological Model. Cambridge: Cambridge Uni-versity Press; 2004:83–84

6 Tyler RS. Neurophysiological models, psychological models, andtreatments for tinnitus. In: Tyler RS, editor. Tinnitus Treat-ments: Clinical Protocols. New York: Thieme Medical Publishers;2006:2–23

7 Kochkin S, Tyler R, Born J. MarkeTrakVIII: Prevalence of tinnitusand efficacy of treatments. Hearing Rev 2011;18(12):10–26

8 Hallam RS. Tinnitus: Living with the ringing in your ears. NewYork: Harper Collins; 1989

9 Jastreboff PJ. Phantom auditory perception (tinnitus): mechanismsof generation and perception. Neurosci Res 1990;8(04):221–254

10 Jastreboff PW. Categories of the patients in TRT and the treatmentoutcome. In: Hazell JWP, editor. Proceedings of the Sixth Interna-tional Tinnitus Seminar 1999. London: The Tinnitus and Hyper-acusis Center; 1999:394–398

11 Attanasio G, Cartocci G, Covelli E, et al. The Mozart effect inpatients suffering from tinnitus. Acta Otolaryngol 2012;132(11):1172–1177

12 Hann D, Searchfield GD, Sanders M, Wise K. Strategies for theselection of music in the short-term management of mild tinni-tus. Aust N Z J Audiol 2008;30(02):129–140

13 Lockwood AH, Salvi RJ, Coad ML, Towsley ML, Wack DS, MurphyBW. The functional neuroanatomy of tinnitus: evidence forlimbic system links and neural plasticity. Neurology 1998;50(01):114–120

14 Leaver AM, Seydell-Greenwald A, Turesky TK, Morgan S, Kim HJ,Rauschecker JP. Cortico-limbic morphology separates tinnitusfrom tinnitus distress. Front Syst Neurosci 2012;6:21

15 Simonetti P, Oiticica J. Tinnitus neural mechanisms and structuralchanges in the brain: the contribution of neuroimaging research.Int Arch Otorhinolaryngol 2015;19(03):259–265

16 Davis PB, Wilde RA, Steed LG, Hanley PJ. Treatment of tinnituswith a customized acoustic neural stimulus: a controlled clinicalstudy. Ear Nose Throat J 2008;87(06):330–339

17 Sweetow RW, Sabes JH. Effects of acoustical stimuli deliveredthrough hearing aids on tinnitus. J Am Acad Audiol 2010;21(07):461–473

18 Kuk F, Peeters H, Lau CL. The efficacy of fractal music employed inhearing aids for tinnitus management. Hearing Rev 2010;17(10):32–42

19 Sweetow RW. The use of fractal tones in tinnitus patient manage-ment. Noise Health 2013;15(63):96–100

20 Herzfeld M, Ciurlia-Guy E, Sweetow R. Clinical trial on theeffectiveness of Widex Zen Therapy for tinnitus the hearing.[Review]. 2014. Available at: http://www.hearingreview.com/2014/10/clinical-trial-effectiveness-widex-zen-therapy-tinnitus

21 Sweetow RW, Fehl M, Ramos PM. Do tinnitus patients continue touse amplification and sound therapy post habilitation? HearingRev 2015;21(03):34

22 Paula Erika Alves F, Cunha F, Onishi ET, Branco-Barreiro FCA,Ganança FF. [Tinnitus Handicap Inventory: cross-cultural adapta-tion to Brazilian Portuguese]. Pro Fono 2005;17(03):303–310

23 Newman CW, Sandridge SA, Jacobson GP. Psychometric adequacyof the Tinnitus Handicap Inventory (THI) for evaluating treatmentoutcome. J Am Acad Audiol 1998;9(02):153–160

24 Al-Jassim AH. The use of Walkman Mini-stereo system as atinnitus masker. J Laryngol Otol 1988;102(01):27–28

25 Davis PB, Paki B, Hanley PJ. Neuromonics Tinnitus Treatment:third clinical trial. Ear Hear 2007;28(02):242–259

26 Okamoto H, Stracke H, Stoll W, Pantev C. Listening to tailor-madenotched music reduces tinnitus loudness and tinnitus-related audi-torycortexactivity.ProcNatlAcadSciUSA2010;107(03):1207–1210

27 Hsü KJ, Hsü AJ. Fractal geometry of music. Proc Natl Acad Sci U S A1990;87(03):938–941

28 Furnham A, Allass K. The influence of musical distraction ofvarying complexity on the cognitive performance of extrovertsand introverts. Eur J Pers 1999;13(01):27–38

29 Newman CW, Weinstein BE, Jacobson GP, Hug GA. The HearingHandicap Inventory for Adults: psychometric adequacy andaudiometric correlates. Ear Hear 1990;11(06):430–433

30 Sweetow R, Kuk F, Caporali S. A controlled study on the effective-ness of fractal tones on subjects with minimal need for amplifica-tion. Hearing Rev 2015;22(09):30



effectof fractal tones on the improvementof tinnitus ... · sents a natural brain function designed...

Documents